Vaccines, Blood & Biologics
Record of Telephone Conversation - Cervarix, October 7, 2009 PM
System Info - 107183 SHONE, DEANNA 07-Oct-2009 14:29:26 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Product:
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Applicant:
GlaxoSmithKline Biologicals
Telecon Date/Time: 07-OCT-2009 02:17 PM Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
Information Request
Author: ROBIN LEVIS
Telecon Summary:
CMC PMC
FDA Participants:
Non-FDA Participants:
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
Sent: Wednesday, October 07, 2009 2:17 PM
To: 'byron.a.bravo@gsk.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'Matt.Whitman@gsk.com'
Subject: RE: Cervarix - CMC PMC
In regard to item 2, we acknowledge your October 2, 2009, commitment (as per Cynthia D'Ambrosio's email).
In regard to item 1, we clarify that long term study results are being requested for -------(b)(4)------- only. If you do, at some point, change the -------------------------(b)(4)--------------------------, it will be necessary to submit those data to the BLA.
Please state your commitment to the following postmarketing commitments:
---------------------(b)(4)------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- --------------------------------------------------------------------------------------------------------- --------------------------------------------------------------------------------------------------- ------
---------------------(b)(4)----------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------- -----------------------------------------
